The phase 3 clinical trial will test the vaccine in 1,400 adults at sites in California and Oregon.
Oakland, Calif. — Today,
Kaiser Permanente began participating in a phase 3 clinical trial to
test an investigational vaccine against SARS-CoV-2, the virus causing
the current COVID-19 global pandemic. Kaiser Permanente plans to enroll
approximately 1,400 participants at 4 sites in California and Oregon.
The goal for this trial is to enroll up to 30,000 participants at more
than 120 sites around the world. The investigational vaccine being
tested in this trial is BNT162b2, one of the vaccine candidates in
development by Pfizer, Inc., and BioNTech, which are also the sponsors
of the study.
The
clinical trial is being conducted by investigators at the Kaiser
Permanente Center for Health Research in Portland, Oregon; the
Department of Research & Evaluation in Pasadena, California; and the
Division of Research in Oakland, California.
Nicola Klein, MD, PhD, Director, Vaccine Study Center.
“Kaiser Permanente is extremely well-positioned to address this public health emergency,” said Nicola Klein, MD, PhD, director of the Kaiser Permanente Vaccine Study Center and
principal investigator for the trial in Northern California. “We have
been a leader in vaccine research for more than 30 years and have
participated in clinical trials for almost every vaccine that has been
licensed in the United States. We know we can meaningfully contribute to
helping determine whether this vaccine is effective in preventing
COVID-19 disease.”
“Our
researchers and physicians are eager to contribute to the independent
science that will ultimately lead to the development of a vaccine for
COVID-19,” said Stephen Fortmann, MD, senior science director and principal investigator for the trial at the Kaiser Permanente Center for Health Research.
“We are working in partnership with researchers globally to ensure
timely, safe, and effective vaccines can be developed so that we can
prevent illness and save lives.”
“This virus is a tremendous health threat and has affected the world profoundly both economically and socially,” said William J. Towner, MD,
regional physician director, Division of Clinical Trials Research, and
principal investigator for the trial at Kaiser Permanente’s Department of Research & Evaluation. “It is imperative that we find a safe and effective vaccine as quickly as possible.”
Kaiser
Permanente clinical trial participants must be adult health plan
members aged 18 to 85 years old who are not pregnant or planning to
become pregnant during the trial.
The
phase 3 trial is a randomized trial in which half of the participants
will receive the vaccine and half will receive a placebo. Neither the
participants nor the clinicians will know who is receiving the vaccine
versus the placebo (known as a double-blind study). During this phase of
the trial, data will be gathered about safety, immune response, and
efficacy as required for regulatory review.
Kaiser Permanente also is playing an integral role in the development of another COVID-19 investigational vaccine,
co-developed by the National Institute of Allergy and Infectious
Diseases and Moderna, Inc. The Kaiser Permanente Washington Health
Research Institute in Seattle was the first site to enroll participants
in the phase 1 trial. The vaccine began phase 3 trials at the end of
July.
Read more about Kaiser Permanente’s role in research, including research developing treatments and vaccines, or learn more about this clinical trial.
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About the Kaiser Permanente Division of Research
The
Kaiser Permanente Division of Research conducts, publishes and
disseminates epidemiologic and health services research to improve the
health and medical care of Kaiser Permanente members and society at
large. It seeks to understand the determinants of illness and
well-being, and to improve the quality and cost-effectiveness of health
care. Currently, DOR’s 600-plus staff is working on more than 450
epidemiological and health services research projects. For more
information, visit divisionofresearch.kaiserpermanente.org or follow us @KPDOR.
